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NCT Number: NCT07300709

Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation

Hepatorenal Syndrome (HRS) is a serious complication that can occur in patients with liver cirrhosis, characterised by kidney dysfunction, or acute kidney failure (AKI). While it has traditionally been thought that HRS affects structurally normal kidneys and is completely reversible with liver transplantation, recent evidence suggests this may not always be the case.

The purpose of this study is to examine the actual structural changes in the kidneys of patients with HRS through tissue biopsy and advanced molecular analysis. This may help us better understand the disease mechanism and potentially improve treatment approaches. We aim to challenge the current understanding that HRS always occurs in structurally normal kidneys and is always reversible after liver transplantation. This study will provide valuable insights into the pathophysiology of HRS and may lead to improved diagnostic and treatment strategies in the future.

This is a 3-year single center prospective, non-randomised, open label study at Queen Mary Hospital, The University of Hong Kong. All consecutive patients accepted on the liver transplant waiting list will be invited to participate. Patient will undergo several procedures related to liver transplant and kidney assessment, and receive liver transplantation and renal biopsy.

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Key information

Conditions

Hepatorenal Syndrome, Liver Regeneration AKI - Acute Kidney Injury Acute Kidney Injury Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hepatorenal Syndrome Kidney Diseases Liver Diseases Liver Transplant Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient must be able to understand and provide informed consent
  • Age ≥ 18 years of age at time of study entry
  • Accepted for liver transplantation (LT)
  • Fulfill the diagnostic criteria of HRS AKI according to International Club of Ascites (ICA) guidelines

3-month post transplant renal biopsy inclusion criteria:

  • Patient with adequate intraoperative renal biopsy
  • Patient must be able to understand and provide informed consent

Exclusion criteria

  • Inability or unwillingness to give written informed consent
  • Patient with known pre-existing renal disease
  • Patient with solitary kidney
  • Re-transplantation
  • ABO-incompatible LT
  • Fail to provide 3-month post transplant renal biopsy

3-month post transplant renal biopsy exclusion criteria:

  • Graft failure after LT
  • Any condition deemed inappropriate by the PI

Treatment and study plan

Renal Biopsy

Procedure

To examine the actual structural changes in kidneys of patients with HRS through tissue biopsy and advanced molecular analysis, and hope that may help us better understand the disease mechanism and potentially improve treatment approaches

Primary outcomes

  1. Proportion of patients with HRS AKI

    Time frame: up to 3 years

    Proportion of patients with HRS AKI who have normal, reversible or permanent injury on renal histopathology

  2. Histopathological changes

    Time frame: up to 3 years

    Histopathological changes and their association with clinical parameters

Secondary outcomes

  1. Duration of HRS AKI

    Time frame: up to 3 years

    Incidence and duration of HRS AKI

  2. Response to standard treatment (Terlipressin and albumin)

    Time frame: up to 3 years

    Response to standard treatment (Terlipressin and albumin)

  3. Perioperative morbidity

    Time frame: up to 3 years

    Perioperative morbidity including need and duration for renal replacement therapy

  4. Post-transplant renal recovery rates

    Time frame: up to 3 years

    Post-transplant renal recovery rates

  5. Transcriptomic signature differences

    Time frame: up to 3 years

    Transcriptomic signature differences between HRS AKI and non-HRS AKI patients

Study contacts

Contact information is provided by the study sponsor or research team.

Tiffany Wong

CONTACT

[email protected]

+852 22553025

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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